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FDA Approves Remicade With Methotrexate To Inhibit Progression of Joint Damage in Rheumatoid Arthritis

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For the first time, the U.S. Food and Drug Administration (FDA) has approved a drug to inhibit the progression of joint damage in patients with rheumatoid arthritis, a chronic and debilitating disease that affects 2.1 million Americans, mostly women.

The FDA granted marketing approval to Remicade (infliximab), in combination with methotrexate, for inhibiting the progression of structural damage in patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to methotrexate.

“For the first time, we now have a drug that can inhibit the progression of joint damage as well as control the pain and stiffness associated with this disease,” said Michael Spiegel, M.D., ATTRACT trial investigator, Danbury, CT. “This is excellent news for patients. Remicade can have a tremendous impact on patients.”

Remicade with methotrexate was first approved for marketing in October 1999 for the treatment of signs and symptoms of rheumatoid arthritis in patients who have had an inadequate response to methotrexate.

Remicade Inhibits Joint Damage on Two Fronts

In patients with rheumatoid arthritis, joint damage is evident as narrowing of the joint space between bones and erosion of the bones at the joint space. Remicade inhibits both of these conditions.

“Joint damage progression in rheumatoid arthritis has two key components, joint space narrowing and joint erosion. Clinical data demonstrates that Remicade inhibits not only joint erosions but joint space narrowing as well. This provides considerable benefit to patients while also improving the pain and stiffness associated with the disease,” said Thomas Schaible, PhD, senior director, medical affairs, Centocor.

Basis for Approval

Approval was based on 54-week data from the two-year ATTRACT trial (Anti-TNF Trial in Rheumatoid Arthritis with Concomitant Therapy), one of the largest and longest controlled rheumatoid arthritis clinical trials involving 428 patients at 34 centers in North America and Europe.

In the double blind, placebo-controlled, randomized clinical study, patients treated with Remicade in combination with methotrexate were compared to those patients treated with methotrexate plus a placebo. Methotrexate is a standard treatment for many patients with rheumatoid arthritis.

In the ATTRACT trial, progression of joint damage was measured radiographically using the van der Heijde modified Sharp system, which evaluates changes in joint-space narrowing and bone erosion on a 5-point scale (a higher score indicates more damage). Among all Remicade treatment groups, overall median change from baseline for radiographic scores of 0.0 were reported among patients treated with the combination of Remicade plus methotrexate (n=285) compared to a median change of 4.0 for patients treated with methotrexate alone (n=63). A total of 53 percent of Remicade patients demonstrated 0 percent progression .

The methotrexate-only findings (control arm) demonstrated progression comparable to that previously reported for patients with established rheumatoid arthritis treated with methotrexate.

Patients on Remicade plus methotrexate also reported significantly greater relief from the pain and stiffness of the disease as well as a reduction in the number of swollen and tender joints. After 54 weeks of therapy, more than half (52 percent) of those treated with Remicade and methotrexate experienced a reduction in the signs and symptoms of RA as measured by ACR 20, a standard assessment for disease activity, compared to 17 percent of patients receiving methotrexate alone.

“The prospect of having a therapy that can actually inhibit the damage caused by rheumatoid arthritis is extremely exciting,” said Virginia Ladd, president and executive director of the American Autoimmune Related Diseases Association (AARDA). “Rheumatoid arthritis patients and their doctors will now have a new tool at their disposal for managing this terrible disease.”

Remicade Generally Well Tolerated

In the clinical trials, Remicade was generally well tolerated. The most common adverse events included upper respiratory infection, headache, mild reactions to the infusion, sinusitis, rash and cough. There was no increased incidence of serious adverse events or serious infections in patients receiving Remicade and methotrexate compared to those receiving placebo and

methotrexate. The incidence of infusion reactions was also low in Remicade plus methotrexate patients (approximately three percent) for any given infusion compared to those receiving methotrexate alone (approximately two percent).

TNF-alpha mediates inflammation and cellular immune response including response to infection. Serious infections, including sepsis and disseminated tuberculosis, have been reported in patients receiving TNF-blocking agents, including Remicade. Some of these infections have been fatal. Many of the serious infections in patients treated with Remicade have occurred in patients on concomitant immunosuppressive therapy that, in addition to their Crohn’s disease or rheumatoid arthritis, could predispose them to infections.

Caution should be exercised when considering the use of Remicade in patients with a chronic infection or a history of recurrent infection. Remicade should not be given to patients with a clinically important, active infection. Patients should be monitored for signs and symptoms of infection while on or after treatment with Remicade. New infections should be closely

monitored. If a patient develops a serious infection including sepsis, Remicade therapy should be discontinued. Patients should be evaluated for the risk of tuberculosis, including latent tuberculosis. Treatment for tuberculosis should be initiated prior to treatment with Remicade.

Remicade and other agents that inhibit TNF have been associated in rare cases with exacerbation of clinical symptoms and/or radiographic evidence of de-myelinating disease. Prescribers should exercise caution in considering the use of Remicade in patients with pre-existing or recent onset of central nervous system de-myelinating disorders.

About Remicade

Remicade was initially cleared for marketing in the US in 1998, for short term use in patients with Crohn’s disease, a serious gastrointestinal disorder. Centocor currently markets Remicade in the United States. Schering-Plough Corporation has rights to Remicade in all other countries throughout the world, except in Japan and parts of the Far East where Remicade will be marketed by Tanabe Seiyaku, Ltd.

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